Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 80723 

concert, to acquire voting shares of 

Hutsonville Banc Corp., and thereby 

indirectly acquire voting shares of 

Farmers & Merchants Bank of 

Hutsonville, both of Hutsonville, 

Illinois. 

B. Federal Reserve Bank of Kansas 

City (Jeffrey Imgarten, Assistant Vice 

President) One Memorial Drive, Kansas 

City, Missouri 64198. Comments can 

also be sent electronically to 

KCApplicationComments@kc.frb.org: 

1. Jeanette Postier and Stephen 

Postier, both of York, Nebraska; to 

become members of the Postier Family 

Group, a group acting in concert, to 

acquire additional voting shares of 

Henderson State Company, and thereby 

indirectly acquire additional voting 

shares of Henderson State Bank, both of 

Henderson, Nebraska. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2023–25617 Filed 11–17–23; 8:45 am] 

BILLING CODE P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage in or 

To Acquire Companies Engaged in 

Permissible Nonbanking Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/

request.htm. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors, 

Ann E. Misback, Secretary of the Board, 

20th Street and Constitution Avenue 

NW, Washington, DC 20551–0001, not 

later than December 5, 2023. 

A. Federal Reserve Bank of Dallas 

(Karen Smith, Director, Mergers & 

Acquisitions) 2200 North Pearl Street, 

Dallas, Texas 75201–2272. Comments 

can also be sent electronically to 

Comments.applications@dal.frb.org: 

1. First New Mexico Financial 

Corporation, Deming, New Mexico; to 

engage de novo through its subsidiaries, 

ArmsLength, LLC, and Five Seven Five, 

LLC, both of Deming, New Mexico, in 

extending credit and servicing loans 

pursuant to section 225.28(b)(1) of the 

Board’s Regulation Y. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2023–25613 Filed 11–17–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10390 and CMS– 

10865] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by December 20, 2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain . Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Hospice Quality 

Reporting Program; Use: On July 1, 

2014, hospices began using a newly 

created data collection instrument, 


ddrumheller on DSK120RN23PROD with NOTICES1
80724 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 

titled the ‘‘Hospice Item Set’’ (HIS) 

V1.00.0. The HIS is used for the 

collection of quality measure data 

related to the Hospice Quality Reporting 

Program (HQRP), and the HIS V1.00.0 

specified the collection of data items 

that supported seven Consensus Based 

Entity (CBE) endorsed Quality Measures 

(QMs) for hospice. On April 1, 2017, 

hospices began using an updated HIS 

V2.00.0, which includes the same items 

from the HIS V1.00.0 along with the 

addition of several new items for use in 

new measures, measure refinement, 

patient record matching, and future 

public reporting. Data collected from the 

HIS are used to calculate the seven CBEendorsed QMs and the CBE-endorsed 

Hospice and Palliative Care Composite 

Process Measure—Comprehensive 

Assessment at Admission QM. 

During the FY 2021 rule, the Hospice 

Visits when Death is Imminent measure 

pair was removed and replaced with the 

claims-based Hospice Visits in Last 

Days of Life (HVLDL) measure. The 

reduction in provider burden and costs 

occurred when CMS replaced the HISbased HVWDII quality measure via the 

HIS information collection request that 

OMB approved on February 16, 2021. 

CMS is requesting to extend the 

expiration date. The HIS V3.00.0 

consists of data elements that are 

designed to collect standardized, 

patient-level data for the following 

domains of care: pain, respiratory status, 

medications, patient preferences and 

beliefs and values. The HIS V3.00.0 was 

developed specifically for use by 

hospices and contains data elements 

that we can use to collect patient-level 

data to calculate eight CBE endorsed 

quality measures. Form Number: CMS– 

10390 (OMB control number: 0938– 

1153); Frequency: On Occasion; 

Affected Public: State, Local, or Tribal 

Governments, Private Sector (not-forprofit institutions); individuals or 

households; Number of Respondents: 

5,640; Total Annual Responses: 

2,763,850; Total Annual Hours: 

1,323,883. (For policy questions 

regarding this collection contact 

Jermama Keys at (410) 786–7778.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Monoclonal 

Antibodies Directed Against Amyloid 

for the Treatment of Alzheimer’s 

Disease; Use: On April 7, 2022, CMS 

finalized the national coverage 

determination (NCD) to cover FDA 

approved monoclonal antibodies 

(mAbs) directed against amyloid for the 

treatment of Alzheimer’s disease (AD) 

under coverage with evidence 

development (CED) in patients who 

have a clinical diagnosis of mild 

cognitive impairment (MCI) due to AD 

or mild AD dementia, both with 

confirmed presence of amyloid beta 

pathology consistent with AD. For antiamyloid mAbs that have accelerated 

approval, the mAb may be covered in a 

randomized controlled trial conducted 

under an investigational new drug (IND) 

application or any NIH sponsored trial. 

For antiamyloid mAbs that have 

traditional FDA approval (as opposed to 

accelerated approval), the NCD specifies 

coverage under CED in CMS approved 

prospective comparative studies, where 

data may be collected in a registry. In 

addition to satisfying the study criteria 

specified in the NCD, CMS approved 

studies for anti-amyloid mAbs that have 

received traditional FDA approval must 

address all of the questions below: 

• Does the antiamyloid mAb 

meaningfully improve health outcomes 

(i.e., slow the decline of cognition and 

function) for patients in broad 

community practice? 

• Do benefits, and harms such as 

brain hemorrhage and edema, associated 

with use of the antiamyloid mAb, 

depend on characteristics of patients, 

treating clinicians, and settings? 

• How do the benefits and harms 

change over time? 

In order to remove the data collection 

requirement under this coverage with 

evidence development (CED) NCD or 

make any other changes to the existing 

policy, we must formally reopen and 

reconsider the policy. CMS supported 

development of a registry, the 

‘‘Monoclonal Antibodies Directed 

Against Amyloid for the Treatment of 

Alzheimer’s Disease CED Study 

Registry’’ (mAb Registry), to facilitate 

coverage under the NCD. Additionally, 

CMS is working with multiple 

organizations preparing to open their 

own registries. Once more registries are 

available, they will also be listed at 

https://www.cms.gov/medicare/ 

coverage-evidence-development/

monoclonalantibodies-directed-againstamyloid-treatment-alzheimers-diseasead, and clinicians will be able to choose 

which registry to participate in. 

The data collected and analyzed in 

the CMS-supported mAb Registry and 

potential CMS-approved registries will 

be used by to determine if monoclonal 

antibodies directed against amyloid for 

the treatment of Alzheimer’s Disease 

(AD) is reasonable and necessary (e.g., 

improves health outcomes) for Medicare 

beneficiaries under section 

1862(a)(1)(A) of the Act. CMS is 

collecting information to learn more 

about which individuals benefit the 

most from this drug. CMS refers to this 

as coverage with evidence development 

or CED. The information being collected 

via registry will be analyzed to assist 

clinicians and patients make informed 

treatment decisions. Furthermore, data 

from the mAb Registry will assist the 

pharmaceutical industry and the Food 

and Drug Administration (FDA) in 

surveillance of the quality, safety and 

efficacy of these types of drugs. Form 

Number: CMS–10865 (OMB control 

number: 0938–NEW); Frequency: 

Annually; Affected Public: Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

40,000; Number of Responses: 40,000; 

Total Annual Hours: 3,320. (For policy 

questions regarding this collection, 

contact Lori Ashby at 410–786–6322.) 

Dated: November 15, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–25601 Filed 11–17–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10398 #37] 

Medicaid and Children’s Health 

Insurance Program (CHIP) Generic 

Information Collection Activities: 

Proposed Collection; Comment 

Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: On May 28, 2010, the Office 

of Management and Budget (OMB) 

issued Paperwork Reduction Act (PRA) 

guidance related to the ‘‘generic’’ 

clearance process. Generally, this is an 

expedited process by which agencies 

may obtain OMB’s approval of 

collection of information requests that 

are ‘‘usually voluntary, low-burden, and 

uncontroversial collections,’’ do not 

raise any substantive or policy issues, 

and do not require policy or 

methodological review. The process 

requires the submission of an 

overarching plan that defines the scope 

of the individual collections that would 

fall under its umbrella. On October 23, 

2011, OMB approved our initial request 

to use the generic clearance process 

under control number 0938–1148 

(CMS–10398). It was last approved on 

April 26, 2021, via the standard PRA 

process which included the publication 

of 60- and 30-day Federal Register 


ddrumheller on DSK120RN23PROD with NOTICES1